AUNT KS- oatmeal, colloidal powderAUNT KS- oatmeal colloidal powderAUNT KS- oatmeal, collodial powder

1. Otc- Active Ingredients Section
2. Sto Use And See A Doctor If:
3. Otc- Warnings Section
4. Other Information
5. Otc- Purpose Section
6. Inactive Ingredients
7. Keep Out Of Reach
8. Dosage Section
9. Indications And Usage
10. Package Label

Otc- Active Ingredients Section ⮝

Organic Colloidal Oatmeal 1.25%..... Skin Protectant

Sto Use And See A Doctor If: ⮝

Conditions worsen

Symptoms last more than 7 days

Symptoms clear up and reoccur within a few days.

Otc- Warnings Section ⮝

For external use only

when using this product: Keep away from face to avoid inhalation

Avoid contact with eyes

Do not use on wet hair, or allow to dry on wet hair

Other Information ⮝

Store in a dry place

protect from moisture

Otc- Purpose Section ⮝

Uses: Helps treat and prevent diaper rash

Temporarily protects and helps relieve minor skin irritation and itching due to diaper rash.

Inactive Ingredients ⮝

Powdered White Soft Wheat

Keep Out Of Reach ⮝

Keep out of reach of Children

Dosage Section ⮝

Apply as Needed

Use Generous amounts for best results

Indications And Usage ⮝

Uses: Helps treat and prevent diaper rash

Package Label ⮝

AUNT KS oatmeal, colloidal powder

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23264-200 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1.25 g in 100 g

Inactive Ingredients Ingredient Name Strength WHEAT (UNII: 4J2I0SN84Y)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23264-200-03 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2014

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/14/2014

AUNT KS oatmeal colloidal powder

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23264-300 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1.25 g in 100 g

Inactive Ingredients Ingredient Name Strength WHEAT (UNII: 4J2I0SN84Y)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23264-300-03 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2014

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/14/2014

AUNT KS oatmeal, collodial powder

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23264-100 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1.25 g in 100 g

Inactive Ingredients Ingredient Name Strength WHEAT (UNII: 4J2I0SN84Y)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23264-100-03 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2014

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/10/2014

Labeler - Comfy Bottoms, LLC (047137184)

Registrant - Comfy Bottoms, LLC (047137184)

Establishment
Name	Address	ID/FEI	Business Operations
CTL Foods		133541248	manufacture(23264-200, 23264-100, 23264-300)

Revised: 12/2016 Document Id: 44d0bc8a-ec26-43e7-e054-00144ff8d46c 34390-5 Set id: 0748e489-ad72-2db5-e054-00144ff88e88 Version: 4 Effective Time: 20161229 Comfy Bottoms, LLC